The following data is part of a premarket notification filed by Kaye Products, Inc. with the FDA for Child's Walker.
Device ID | K833869 |
510k Number | K833869 |
Device Name: | CHILD'S WALKER |
Classification | Walker, Mechanical |
Applicant | KAYE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ITJ |
CFR Regulation Number | 890.3825 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-08 |
Decision Date | 1983-11-29 |